Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published a recently adopted regulation on state supervision and control. The document prescribes the way the regulating authority should perform its functions when supervising the...
Russia
Roszdravnadzor, the Russian regulating authority in the sphere of medical devices, has published a regulation on state control (supervision) over the circulation of medical devices. The document sets forth the rules and requirements in the sphere of state supervision...
Russia
An order of the Minister of Healthcare of the Russian Federation has been published. The order implements the administrative regulation the Roszdravnadzor shall follow when issuing establishment licenses to the entities engaged in manufacturing and maintenance of...
Europe
The Roszdravnadzor, the Russian federal authority responsible for medical devices regulation, issued recommendations on quality, effectiveness, and safety examination of medical software for the purpose of state registration under the national framework. Eligibility...
Europe
The Russian Federation issued several regulations implementing additional measures to ensure and expand the availability of medical devices that are vitally important during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the...
